HPLC测定注射用头孢曲松钠他唑巴坦钠的含量及其有关物质

Determination of the contents and related substances of Cefriaxone sodium / Tazobactam sodium for injection by HPLC

目的采用HPLC法测定注射用头孢曲松钠他唑巴坦钠的含量及其有关物质。方法采用Kromasil C18色谱柱（250mm×4.6 mm,5μm）,流动相为磷酸缓冲液-乙腈（90∶10）,流速1.0 mL·min^-1,柱温30℃,检测波长230 nm。结果他唑巴坦、头孢曲松含量的线性范围分别为0.05-0.40、0.15-1.20 mg·mL^-1（r=0.9999）,重复性的RSD分别为1.5%、0.5%,平均回收率分别为101.0%、100.9%,定量限分别为0.12、0.04μg;他唑巴坦、头孢曲松有关物质的线性范围分别为2.5-25.3、7.5-75.0μg·mL^-1,r分别为0.9999、0.9998,精密度的RSD分别为2.0%、0.5%,检测限分别为0.04、0.01μg,各杂质与头孢曲松及他唑巴坦两色谱峰均能完全分离。结论所用方法可用于注射用头孢曲松钠他唑巴坦钠的质量控制。

OBJECTIVE To establish an HPLC method for the determination of the contents and related substances of Cefriaxone sodium / Tazobactam sodium for injection. METHODS An Kromasil C18column（ 250 mm × 4. 6 mm,5 μm） was used. The mobile phase was phosphate buffer solution- acetonitrile（ 90∶10）. The flow rate was 1. 0 m L·min^- 1,the column temperature was 30 ℃ and the detection wavelength was 230 nm. RESULTS In terms of contents,the caliblation curve for Tazobactam was linear in the range of0. 05 to 0. 40 mg·mL^-1（ r = 0. 9999）. The RSD of repeatability was 1. 5%; the average recovery was 101. 0% and the quantitative limit was 0. 12 μg. The caliblation curve for Ceftriaxone was linear in the range of 0. 15 to 1. 20 mg·mL^-1（ r = 0. 9999）. The RSD of precision was 0. 5%,the average recovery was 100. 9% and the quantitative limit was 0. 04 μg. In terms of related substances,the caliblation curve for Tazobactam was linear in the range of 2. 5 to 25. 3 μg·mL^-1（ r = 0. 9999）. The RSD of precision was 2. 0% and the detection limit was 0. 04 μg. The caliblation curve for Cefriaxone was linear in the range of 7. 5 to 75. 0 μg·mL^-1（ r = 0. 9999）. The RSD of precision was 0. 5% and the detection limit was 0. 01 μg. Every two peaks of each impurity with Ceftriaxone and Tazobactam could be completely separated. CONCLUSION Through the methodology validation,the method is a new reliable analytical method for the quality control of Cefriaxone sodium / Tazobactam sodium for injection.